H10: manufacturing review: a device history record review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one device was returned for evaluation.The device was noted to still be loaded into a sheath with the distal end buckled.The device was then successfully flushed and inserted with an in house syringe and guidewire respectively.An in house presto device was used to inflate the device to nominal pressure, the balloon was noted to maintain uniform shape and pressure.The balloon was then deflated without issues and the deflation time was in spec with pps-8070.However, the device had difficulty being retracted through the sheath and bunching was noted to be forming at the proximal end.Therefore the alleged failure deflate can be unconfirmed for, as the balloon was able to be inflated and deflated without issues during evaluation.The investigation is confirmed for the retraction issue, as the device was noted to have resistance and buckling was noted when device was retracted through the sheath during evaluation.The reported deflation issue most likely contributed to the reported retraction issue.However, the definitive root cause for the reported deflation and retraction issue could not be determined.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 03/2023).H11: section a through f: the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : see h10.
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